Prescription drug · ANDA
Gallifrey (norethindrone acetate) NDC 70700-326
Norethindrone acetate 5 mg/1 · Tablet · Oral · Xiromed LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70700-326-50 | 70700032650 | 50 TABLET in 1 BOTTLE (70700-326-50)Marketed from Sep 6, 2024 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Gallifrey
- Generic name (nonproprietary)
- norethindrone acetate
- Active ingredients
- Norethindrone acetate — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Xiromed LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205278
- Marketing start
- Listing expires
- Other FDA classes
- Progesterone Congeners (Chemical structure)
- Identifiers
- Product ID 70700-326_87e7c941-eb02-5980-fc0e-08aee9b00f75SPL ID 87e7c941-eb02-5980-fc0e-08aee9b00f75SPL set ID 26130af6-221b-2349-81b6-0c0132d6e524RxCUI 1000405, 2696255UNII 9S44LIC7OJ
- Pharmacologic class
- Progestin
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N470700032650followed by a unit qualifier and the quantityPackage 70700-0326-50. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS AND USAGE Gallifrey (Norethindrone Acetate Tablets, USP), 5 mg Gallifrey is indicated for the treatment of secondary amenorrhea, endometriosis, and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer. Gallifrey is not intended, recommended or approved to be used with concomitant estrogen therapy in postmenopausal women for endometrial protection.
Excerpt only. Read the full label for complete information.